{SPECIAL ARTICLE} PHARMACOVIGILANCE OVERVIEW IN INDONESIA

Even though that the history of pharmacovigilance started in the end 1950s (or early 1960s) after Thalidomide tragedy, the mechanism of pharmacovigilance established after years later. The usage of “Yellow Card scheme” was first developed in England in 1964 as a response for Thalidomide tragedy, to collect necessary…

PIC/S BAB IV (DOKUMENTASI) – DOKUMEN CPOB YANG DIBUTUHKAN

PIC/S BAB IV (DOKUMENTASI) – DOKUMEN CPOB YANG DIBUTUHKAN NO VERSI ASLI VERSI TERJEMAHAN Site Master File: A document describing the GMP related activities of the manufacturer. Dokumen Induk Perusaahaan: Dokumen yang menjelaskan tentang kegiatan produsen yang terkait dengan CPOB. INTERPRETASI SMFberisi penjelasan pabrik. Berisi…

PIC/S BAB IV (DOKUMENTASI) – PRINSIP

PIC/S BAB IV (DOKUMENTASI) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be…

PIC/S BAB III (FASILITAS DAN PERALATAN) – PERALATAN

PIC/S BAB III (FASILITAS DAN PERALATAN) – PERALATAN NO VERSI ASLI VERSI TERJEMAHAN 3.34 Manufacturing equipment should be designed, located and maintained to suit its intended purpose. Peralatan produksi harus dirancang, ditempatkan dan dirawat sesuai dengan tujuannya. INTERPRETASI Bila proses produksi obat baru menggunakan peralatan…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENGAWASAN MUTU

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 3.26 Normally, Quality Control laboratories should be separated from production areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENYIMPANAN

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENYIMPANAN NO VERSI ASLI VERSI TERJEMAHAN 3.18 Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PRODUKSI

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PRODUKSI NO VERSI ASLI VERSI TERJEMAHAN 3.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly…

Apa Perbedaan antara GMP Eropa (EU GMP) dan GMP Amerika (FDA GMP)?

Kedua pedoman ini sebenarnya memiliki banyak kesamaan, namun demikian terdapat beberapa perbedaan. Misalnya: Pengkajian Produk Tahunan atau Pengkajian Mutu Produk Tujuan dari “Annual Product Review” (APR) atau Pengkajian Produk Tahunan menurut FDA adalah untuk mengkaji standar mutu setiap produk dan menentukan adanya kebutuhan terhadap perubahan spesifikasi…